Thursday, May 15, 2008

Sue the FDA? Not if Bush can help it.

I find this story, which I only just learned of (the lack of coverage on the subject is a tragedy in and of itself) to be deeply disturbing. Read on.

Drug lawsuit suppression bad for Americans' health

Oakland Tribune, April 13, 2008

IN OCTOBER, if the Bush administration has its way with the Supreme Court, you will lose the right to sue a drug company if you are harmed by a medication that was FDA approved. Even if, like me, you think our country is lawsuit happy, this prospect portends bad news for your health.

The pivotal case pending before the Supreme Court involves a musician, Diana Levine, who lost her arm to gangrene after she was inappropriately injected with a drug manufactured by Wyeth pharmaceuticals. But after she won a lawsuit against Wyeth, the Bush administration partnered with Wyeth to challenge her win at the Supreme Court.

Why would the administration be so interested in a lone citizen's case against a drug company? Because it has a much larger aim: the entire U.S. population. It will argue, along with the drug company, that no citizen should be allowed to sue a drug maker for injuries associated with an FDA-approved drug. It will claim that such lawsuits might undermine the FDA's authority, and that FDA approval ought to provide the definitive word on a drug's merit and safety.

It doesn't seem to matter that we frequently are ambushed by a drug's side effects or false claims only months to years after a drug's FDA approval. It doesn't seem to matter that too often we are told only in retrospect about drug company research that somehow bypassed the original FDA evaluation.

And "undermine" the FDA? Even the FDA's own science advisory board last year concluded that the FDA was "so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety." The Government Accountability Office and the Institute of Medicine reached similar conclusions.

Private lawsuits against manufacturers of defective or unsafe drugs actually have provided a safety net for the public. They have brought to light harmful and lethal side effects of drugs that somehow escaped notice during the FDA approval process. More accurately, they should be viewed as serving the FDA's own organizational mission to promote public health and safety.

Like product liability lawsuits brought against manufacturers of defective cars or tires, lawsuits brought against makers of faulty drugs also seek to hold manufacturers accountable for the integrity of their products and business practices. They allow people injured by bad drugs to obtain justice and compensation.

If drug companies were required to hand over all of their drug research -- the good, the bad and the ugly -- to a robust FDA, and if the data were medically sound, objectively interpreted and transparently published, I could understand granting those companies legal immunity. But we know that's not how drug companies always operate. Allegations of drug company shenanigans regularly fill our weekly news reports.

To top it off, most Americans don't know that drug companies actually pay the FDA to evaluate new drugs as quickly as possible. An agreement was reached in 1992 that allowed the FDA to collect fees from pharmaceutical companies in exchange for promising to deliver quicker drug approvals. In fact, the FDA depends upon drug companies for nearly half of its $680million review process for new drugs. There aren't enough exclamation marks to indicate the alarm that should sound from this disturbing fox-in-the-henhouse arrangement.

For all these reasons, it's flat-out disingenuous for pharmaceutical companies to hide behind the FDA's skirts. And it's flat-out wrong for the Bush administration to abolish citizens' rights to fend for themselves in court while it simultaneously underfunds a compromised drug regulatory agency.

But the Bush administration already has secured a Supreme Court decision that bars Americans from bringing lawsuits against the manufacturers of medical devices that receive FDA approval. Unlike pharmaceuticals, devices -- such as pacemakers, defibrillators or joint replacements -- exert their intended effects on humans without involving metabolism or chemical reactions. The court decision stemmed from a case in February in which the Justices ruled that Donna Riegel could not sue Medtronic, manufacturer of a FDA- approved balloon catheter that burst inside her husband's artery during angioplasty.

Encouraged by the Supreme Court's ruling on medical devices, the Bush administration and drug companies hope to win a similar decision this fall regarding FDA-approved pharmaceuticals. Should they prevail again, they will have further restricted the rights of patients injured by drugs or devices to have their day in court to seek a legal remedy.

I worry that there seems to be so little public and Congressional outcry against the Court's erroneous decision in February and minimal public attention to the upcoming pharmaceutical case in October. I am deeply concerned about the behavior of the administration, which truly undermines the FDA by underfunding its operations and allowing it to depend on drug company money. It's blatant public betrayal that the administration has sided with drug and device makers to fight for Supreme Court rulings that deprive us of basic rights to protect ourselves and use the judicial system to redress powerful wrongs.

Does it matter that drug and medical device companies spent more than $50 million on lobbying the federal government last year? Our civil liberties are being dismantled all the while that our government builds protective walls around drug and device manufacturers.